Paving the way for Personalized Medicine
On October 31st 2013, FDA published a new report titled: Paving the Way for Personalized Medicine – FDA’s Role in a New Era of Medical Product Development
http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf
The FDA report describes their perspectives on Personalized Medicine, Pharmacogenomics, Personalized Medical Devices, Targeted Therapy, Companion Diagnostics, and Whole Genome Sequencing.
Commitment to Personalized Medicine
The FDA announces their commitment to advancing personalized medicine and the report outlines the FDA’s role, responsibilities, and challenges relating to products and technologies that are key to personalized medicine field.
The report gives some good background on the definition of personalized medicine, some history of personalized medicine initiatives, and mentions some of the challenges of Laboratory Developed Tests (LDTs), Companion Diagnostics, and post-market surveillance.
Directional Guidance
In the report, FDA has taken a quite expansive definition and highlights a broad suite of related guidance documents that laboratories, medical device manufacturers, and healthcare software providers should be keenly aware of.
Exciting road ahead to personalized medicine and precision medicine.
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